đź“‹ FDA Reference
titan micro catheter model 105-5074-153 hd injector model 103-0305
Micro Therapeutics
Summary: The Titan Micro Catheter is a medical device used for delivering embolization coils in vascular procedures. It is primarily used by interventional radiologists and neurosurgeons for treating aneurysms and other vascular abnormalities.
FDA Clearance Information
Pathway
510K
Number
K022003 ↗
Decision Date
September 13, 2002
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Titan Micro Catheter, manufactured by Micro Therapeutics, was cleared through the FDA 510(k) pathway on September 13, 2002. It is classified as a Class 2 device under product code DYB.
What It Is
The Titan Micro Catheter is a specialized catheter designed for precise delivery of embolization coils into blood vessels. It features a flexible, small-diameter design that allows navigation through complex vascular structures. This device is crucial in minimally invasive procedures where access to small or tortuous vessels is required.
Clinical Applications
Commonly used in interventional radiology and neurosurgery, the Titan Micro Catheter is employed in procedures such as embolization of cerebral aneurysms and arteriovenous malformations. It is particularly useful in hospital settings where advanced imaging techniques guide the catheter through the vascular system. The device is suitable for adult patients with vascular conditions requiring coil embolization.
Indications for Use
The FDA-cleared indications for the Titan Micro Catheter include its use in delivering embolization coils to treat vascular abnormalities like aneurysms. It is intended for patients who need minimally invasive treatment to prevent or manage vascular complications.
Practical Considerations
The Titan Micro Catheter comes in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with standard embolization coils and requires careful handling to navigate through delicate vascular pathways. Clinicians should be trained in catheter-based interventions for optimal use.
Frequently Asked Questions
What is the Titan Micro Catheter used for?
It is used for delivering embolization coils to treat vascular abnormalities such as aneurysms.
What specialties typically use this device?
Interventional radiologists and neurosurgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for the delivery of embolization coils in treating vascular abnormalities like aneurysms.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.